Results 61 to 70 of about 13,126 (223)

Postmarketing Surveillance Based on Electronic Patient Records: The IPCI Project

, 1999
Researchers claim that data in electronic patient records can be used for a variety of purposes including individual patient care, management, and resource planning for scientific research. Our objective in the project Integrated Primary Care Information
A. E. Vlug, B. M. Th. Mosseveld, M. A. M. van Wijk, J. H. van Bemmel, M. C. J. M. Sturkenboom, J. van der Lei, P. D. van der Linden   +6 more
core   +1 more source

The implementation of rifapentine and isoniazid (3HP) in two remote Arctic communities with a predominantly Inuit population, the Taima TB 3HP study

International Journal of Circumpolar Health, 2020
Background: The incidence of TB among Inuit is the highest in Canada. A significantly shorter latent TB infection (LTBI) treatment with rifapentine and isoniazid once weekly for 12 weeks (3HP) is now available in limited settings in Canada.
G. G. Alvarez, D. Van Dyk, R. Mallick, S. Lesperance, P. Demaio, S. Finn, S. Edmunds Potvin, M. Patterson, C. Pease, K. Amaratunga, C. Hui, D.W. Cameron, S. Mulpuru, S.D. Aaron, F. Momoli, A. Zwerling   +15 more
doaj   +1 more source

A Case of Acalculous Cholecystitis During Lenvatinib Plus Pembrolizumab Therapy for Advanced Renal Cell Carcinoma

IJU Case Reports, Volume 9, Issue 4, July 2026.
ABSTRACT Introduction Lenvatinib plus pembrolizumab is a standard first‐line therapy for advanced renal cell carcinoma (RCC), and acute acalculous cholecystitis is a rare adverse event. Case Presentation A 60‐year‐old woman with metastatic TFE3‐positive non–clear cell RCC, classified as poor risk by the International Metastatic RCC Database Consortium (
Erika Soga, Go Noguchi, Kota Kobayashi, Rio Shibata, Ryosuke Jikuya, Tomoyuki Tatenuma, Mitsuru Komeya, Hiroki Ito, Hisashi Hasumi, Kazuhide Makiyama   +9 more
wiley   +1 more source

Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths

Clinical and Translational Science, 2019
Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which “local” dose‐ranging and/or pivotal phase III studies ...
Tomoko Kawamura Okubo, Shunsuke Ono
doaj   +1 more source

Glycolytic metabolism of CD8+ T‐cells affects susceptibility to human leukocyte antigen‐mediated abacavir‐induced hypersensitivity

British Journal of Pharmacology, Volume 183, Issue 13, Page 3743-3761, July 2026.
Abstract Background and Purpose Drug hypersensitivity reactions (DHRs) associated with a specific human leukocyte antigen (HLA) allotype do not manifest uniformly in all individuals within an HLA model population. This scenario highlights the complexity of predicting drug hypersensitivity reaction risk without considering additional factors ...
Takeshi Susukida, Yuchen Sun, Noriaki Arakawa, Takuya Hirao, Tadahaya Mizuno, Shigeki Aoki, Kousei Ito, Yoshihiro Hayakawa   +7 more
wiley   +1 more source

Immune Checkpoint Inhibitor-Induced Pneumonitis in Non-Small Cell Lung Cancer: A Narrative Review of Incidence and Clinical Risk Factors

Current Oncology
It is well-known that immune checkpoint inhibitors (ICIs) can lead to uncommon but potentially life-threatening immune-related adverse events (irAEs) such as checkpoint-inhibitor pneumonitis (CIP).
Olexiy Aseyev, Liliia Zrielykh, Minghan Shi, Katherine Filipovic, Claire Seymour, Rabail Siddiqui, Birubi Biman   +6 more
doaj   +1 more source

Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative

Clinical Pharmacology &Therapeutics, Volume 119, Issue 6, Page 1514-1521, June 2026.
The U.S. Food and Drug Administration (FDA) used an Active Postmarket Risk Identification and Analysis (ARIA) system to address a safety issue (serious infection) identified during clinical review of an application to market ustekinumab as a treatment for Crohn's disease (CD). FDA used an active‐comparator new‐user cohort design, data from six Sentinel
Joel L. Weissfeld, Geetha S. Iyer, Suna C. Seo, Andrew Giffin, Andrew L. Simon, Sheryl A. Kluberg, Emma R. Hoffman, Jamal T. Jones, Sarah K. Dutcher, Joyce A. Korvick   +9 more
wiley   +1 more source

Various approaches to postmarketing drug safety monitoring

, 2021
Before being launched on the market, a medicinal product must have been demonstrated of good quality, effective and safe. However, rare adverse drug reactions or those occurring after long-term use may not always be detected during the clinical ...
Ing Lorenzini, Kuntheavy
core   +1 more source

Toxicological Evaluation of the Undesirable Components in Processed Infant Foods Using Artificial Intelligence

Future Postharvest and Food, Volume 3, Issue 2, Page 185-205, June 2026.
The detection of toxins in baby food using artificial intelligence. ABSTRACT Infant foods and baby formulas are becoming increasingly popular across the globe owing to their ease of consumption and nutritional value specific to infants. Impurities may find their way into the food chain at any point from the acquisition of raw materials to final ...
Poornima Singh, Anurag Singh, Ashutosh Upadhyay, Navneet Kumar   +3 more
wiley   +1 more source

Postmarketing Requirements

, 2005
This chapter introduces the intricate regulatory scheme of postmarketing regulations that restrict the commercialization of medical devices. Co-authored with Royce W. Smith, Esq.
Janssen, William M
core